Part 11, Electronic Records; Electronic Signatures
The Applicability of the Uniform Commercial Code and any other laws that direct the application of the laws of any other jurisdictions are expressly excluded. By continuing to access or use our Software after any revisions become effective, you agree to be bound by the revised terms. If you do not agree to the new terms, you are no longer authorized to use the Software. As an outgrowth of its current good manufacturing practice initiative for human and animal drugs and biologics,4 FDA is re-examining part 11 as it applies to all FDA regulated products. We anticipate initiating rulemaking to change part 11 as a result of that re-examination. While the re-examination of part 11 is under way, we intend to exercise enforcement discretion with respect to certain part 11 requirements. That is, we do not intend to take enforcement action to enforce compliance with the validation, audit trail, record retention, and record copying requirements of part 11 as explained in this guidance. Howeve